大腸菌によるVLPワクチンの生産 日本

• 大腸菌VLP生産

  このプロセスでは合成 VLP が作られます。大腸菌の助けを借りれば、科学者にとってははるかに高速でコスト効率の良い方法です。これは、動物細胞を必要とし、非常に複雑だった古い方法よりも確実に速いワクチン製造方法です。古い方法では、ワクチンの製造に数か月、場合によっては数年かかりますが、人々が亡くなるので、これは良くありません。

• 大腸菌技術でVLPワクチン製造が可能に

  ワクチン製造における大腸菌技術の導入は、特にパンデミックの際の医療分野に革命をもたらしました。これにより、ワクチンの製造もより安価になり、より速く、より簡単になりました。この新しいアプローチにより、特に複雑なウイルスなど、これまでワクチン接種が困難だった病気に対するワクチンの作成も可能になりました。

• 大腸菌を使ったワクチン製造の画期的変化

  大腸菌を使用したウイルス様粒子の生産: Namedoji 技術は、インフルエンザ、エボラ、ヒトパピローマウイルスのワクチンとして開発するために、細菌内で自己組織化 VLP を効率的に発現させることに基づいています。これらのワクチンは人々を病気から守ります。この技術は、このパンデミックを終わらせ、人命を救う鍵となった Covid-19 ワクチンの製造にも大きな役割を果たしました。

大腸菌における Yaohai VLP ワクチン製造を選択する理由は何ですか?

• 専門知識と豊富な経験

  Yaohai Bio-Pharma, a leader in CDMOs for microbial biologics, is located in Jiangsu. We are focusing on microbially produced therapeutics and vaccines that are VLP Vaccine Production in E. coli for human, veterinary as well as pet health management. We have the most cutting-edge RD platforms as well as manufacturing technology that cover the entire manufacturing process, from microbial strain development, cell banking, process and method development to clinical and commercial manufacture which ensures successful production of novel solutions. We have gained an extensive amount of experience in bio processing of microbial cells. More than 200 projects have been successfully completed, and we support our clients in get through regulations, such as those of US FDA as well as EU EMA. We also aid them with Australia TGA and China NMPA. Our experience and professional knowledge as well as our extensive knowledge allow us to quickly respond to market demands and provide customized CDMO services.

• 品質システムとグローバル規制コンプライアンス

  Yaohai BioPharma, a top 10 Microbial CDMO that integrates quality management and regulatory affairs. Our quality system that is compliant with current GMP standards as well as international regulations. Our team of regulatory experts is proficient in global regulatory frameworks to accelerate biological launches. We ensure traceable production procedures quality products, as well as conformity with the requirements of the VLP Vaccine Production in E. coli and EU EMA. Australia TGA and China NMPA are also met. Yaohai BioPharma successfully passed an in-person audit conducted by a Qualified Person of the European Union (QP) to examine our GMP system and production facility. We also completed the initial certification audits of the ISO9001 Quality Management System and ISO14001 Environmental Management System.

• 強力なサプライチェーンと製造能力

  Yaohai Bio-Pharma, a top 10 producer of biological products, is a specialist in microbial fermentation. We have established an advanced facility that is equipped with modern facilities and strong RD manufacturing capabilities. We have five drug substance manufacturing lines that are in compliance with GMP requirements for microbial fermentation and purification, as well as two fill-finish lines that are automated for cartridges, vials, as well as pre-filled syringes. The available fermentation scales vary from 100L to 500L, 1000L and 2000L. VLP Vaccine Production in E. coli for vias are 1ml to 25ml, whereas the pre-filled syringes and cartridge filling specifications cover 1-3ml. Our production workshop is cGMP compliant and guarantees steady supply of clinical samples as well as commercial items. Our plant produces large molecules which are shipped to the globe.

• カスタマイズ、効率性、コスト効率

  Yaohai Bio-Pharma has experience in the production of biologics created from VLP Vaccine Production in E. coli. We offer customized RD and manufacturing solutions while making sure that there are no risks. We have been involved in diverse modalities such as subunit vaccines recombinant, peptides hormones, cytokines, growth factors, single-domain antibodies enzymes, plasmid DNA MRNA, and many more. We are a specialist in many microorganisms, including yeast extracellular and intracellular secretion (yields up to 15g/L) as well as bacteria intracellular soluble and inclusion body (yields as high as 10g/L). We have also created a BSL-2 fermentation platform to create bacterial vaccines. We focus on improving processes, increasing product yields, and reducing production costs. Utilizing a strong technology team, we can ensure prompt and reliable project delivery that will bring your product to market faster.

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